Trial record 2 of 5 for:    Open Studies | "Pregnancy, Multiple"

Perineal Consequences of Twin Pregnancies According to Mode of Delivery (JUMODA-CP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT02059746
First received: February 7, 2014
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

This is an ancillary study to the "JUMODA" (National Prospective and Comparative Study on the Mode of Delivery of Twins) study: please see NCT01987063.

The main objective of this study is to investigate the role of the mode of delivery (vaginal versus cesarean) as a risk factor for the occurrence of urinary incontinence at 3 months post-delivery in primiparous women delivering twins after 34 weeks of pregnancy.


Condition Intervention
Pregnancy, Multiple
Other: Questionnaires sent by mail

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perineal Consequences of Twin Pregnancies According to Mode of Delivery

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Presence/absence of urinary incontinence [ Time Frame: 3 months post-partum ] [ Designated as safety issue: No ]
    Defined by a response of 1 to 5 on the first question of the ICIQ-UI questionnaire.


Secondary Outcome Measures:
  • The ICIQ-UI questionnaire [ Time Frame: 3 months post-partum ] [ Designated as safety issue: No ]
    ICIQ-Urinary Incontinence Form

  • The PFDI-20 questionnaire [ Time Frame: 3 months post-partum ] [ Designated as safety issue: No ]
  • The ICIQ-UI questionnaire [ Time Frame: 12 months post-partum ] [ Designated as safety issue: No ]
    ICIQ-Urinary Incontinence Form

  • The PFDI-20 questionnaire [ Time Frame: 12 months post-partum ] [ Designated as safety issue: No ]
  • The PFIQ-7 questionnaire [ Time Frame: 3 months post-partum ] [ Designated as safety issue: No ]
  • The PFIQ-7 questionnaire [ Time Frame: 12 months post-partum ] [ Designated as safety issue: No ]
  • The PISQ-12 questionnaire [ Time Frame: 3 months post-partum ] [ Designated as safety issue: No ]
  • The PISQ-12 questionnaire [ Time Frame: 12 months post-partum ] [ Designated as safety issue: No ]
  • The SF-12 questionnaire [ Time Frame: 3 months post-partum ] [ Designated as safety issue: No ]
  • The SF-12 questionnaire [ Time Frame: 12 months post-partum ] [ Designated as safety issue: No ]

Estimated Enrollment: 2160
Study Start Date: February 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Vaginal birth

Patients in the group give birth vaginally.

Intervention: Questionnaires sent by mail

Other: Questionnaires sent by mail
The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum.
Cesaren section

Patients in this group give birth via cesarean section.

Intervention: Questionnaires sent by mail

Other: Questionnaires sent by mail
The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum.

Detailed Description:

The secondary objectives of this study are to compare the following elements between primiparous mothers giving birth to twins vaginally versus by caesarean section after 34 weeks of pregnancy (comparisons will be made at 3 months ant at 12 months post-partum):

A. Diagnosis, type and severity of urinary incontinence via the ICIQ-UI questionnaire

B. Urinary, anorectal and perineal symptoms via the PFDI-20 questionnaire

C. Quality of life related to urinary, anorectal and pelvic floor symptoms via the PFIQ-7 questionnaire

D. Sexuality via the PISQ-12 questionnaire

E. General quality of life via the SF-12 questionnaire

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This is an ancillary to the "JUMODA" study (please see NCT01987063). The study population is composed of primiparous women pregnant with twins (non primiparous patients in the study JUMODA will therefore not includable), giving birth after 34 weeks to 2 live children.

Criteria

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 12 months of follow-up following delivery
  • The patient was included in the JUMODA study
  • Primiparous
  • Birth of 2 live children after 34 weeks of pregnancy

Exclusion Criteria:

  • Adult patient under guardianship
  • Patient under judicial protection
  • It proves impossible to correctly inform the patient
  • Birth occurring before 34 weeks of pregnancy
  • Birth not resulting in 2 living children
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059746

Contacts
Contact: Renaud de Tayrac, MD, PhD +33.(0)4.66.68.32.16 renaud.detayrac@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHRU de Montpellier - Hôpital Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 9, France, 30029
Principal Investigator: Renaud de Tayrac, MD, PhD         
Sub-Investigator: Vincent Letouzey, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Study Director: Renaud de Tayrac, MD, PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02059746     History of Changes
Other Study ID Numbers: AOI/2013/RdeT, EGY/TDG/AR141876
Study First Received: February 7, 2014
Last Updated: April 4, 2014
Health Authority: France: The Commission nationale de l’informatique et des libertés
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
cesarean section
vaginal birth
twins
urinary incontinence
sexuality
quality of life

ClinicalTrials.gov processed this record on July 23, 2014